2021 China NMPA (CFDA) Bluebook

2021 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulations

China’s overhaul of medical device and IVD regulations could mean huge benefits. Manufacturers have additional options for fast-track approvals and more flexible testing / clinical-evaluation pathway requirements. Is your company positioned to benefit from faster and less-costly market entry?

Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China. This all-in-one resource provides an overview on many new regulations, along with clear explanation of how these could affect your registrations, renewals and post-market compliance.

Get your copy of the 2021 Blue Book today with the completion of a survey:

This 60+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Quality Management System, COVID-19, CDx and specific products for attention:

  • Two geographic pilot zone policies- Hainan & Great Bay Area (GBA) to allow unapproved medical device to be clinically used
  • How the Electronic Regulated Product Submission (eRPS) system under NMPA will affect submission process
  • New China Unique Device Identification (UDI) database and submission procedure.
  • Revised standards for 83 medical devices and IVDs
  • Innovation devices eligible for 3 new Fast-Track channels
  • 68 Clinical trial exemptions and new procedure that could expedite all clinical trials
  • Major changes to medical device quality inspection
  • New mandatory Period Risk Evaluation Report (PRER) requirements
  • Emergency approval: COVID-19 related medical device
  • Key requirements and updates for IVD & CDx
  • Plus, an extensive index of regulatory documents issued in 2020 covering Law & Regulation, Policy, Technical Guideline and Industry Standards, Clinical Related Guidelines and In-Depth Evaluation Report written by the reviewers.

The China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.

— Mr Gong Zhi Jun, Director Administration Institute of Executive Development NMPA